GMPs: Lost in Transition?

One of the very first slides in the Natural Products Association’s “Good Manufacturing Practices: Preparing for Certification Seminar” states that “DSHEA amended the Federal Food, Drug, and Cosmetic Act to allow for the establishment of good manufacturing practices (GMPs) for dietary supplements.”

Fast forward from 1994, the year DSHEA was passed, to 2007. In those 13-plus years, there has been one advanced notice of proposed rule making (ANPR) in 1997 and one proposed rule in 2003, but no final ruling on dietary supplement GMPs (outside of the Food and Drug Administration’s Food GMP standards). While a transition to federal dietary supplement GMP regulations looms like a cloud, the industry has confidently and repeatedly stated “issue the final rule, regulate us properly, and give us a level playing field to show we are manufactured with the highest quality.” Although such bold statements may be part of a response to media reports portraying dietary supplements as unregulated, a percentage of the industry has invested in third-party certification programs, effectively stating by their actions that they are ready, willing and (most importantly) able to meet a higher standard of manufacturing quality.

The general mission of any third-party GMP certification program is to maintain and elevate the standards of dietary supplement manufacturing through evaluation and accreditation of organizations. The certification programs contract auditors who are sent to supplement manufacturing facilities to evaluate their operational practices and facilities. While that sounds terrific in sound bites, it does not define the value a third-party GMP certification program may bring. GMPs in essence are good business. They optimize processes, procedures and record keeping that will improve productivity. Improving productivity will afford the ability to produce more and potentially improve profitability. It will definitely improve profitability by decreasing costs associated with reworking materials, scrap, contamination, mix-ups and errors. Those savings could permit further investments in research and development, efforts to expand market share with a brand new product, etc. Whether your company is a finished product manufacturer, contract manufacturer or raw material supplier, competition in the marketplace is tougher than it has ever been. While a number of forums exist that are very efficient at bringing buyers and sellers together for price discovery, signaling and interpreting the actual value and quality of ingredients at such venues is often a challenge. This is particularly true for those who have an urgent demand to fill. As with any marketplace, the root of the problem is that buyers cannot assess the quality of dietary supplements or ingredients at a low cost, and sellers have incentive to portray the quality of their product in the best manner possible. If structured correctly, third party certification programs have the potential to mitigate this problem—provided buyers trust the integrity of programs and procedures.

Third-party GMP certification is independent, meaning it provides an objective review of manufacturing performance free from both the economic demands of the marketplace and internal company pressures because the third-party auditors have no financial interest in the sale of products nor an interest in promotion to the corner office. While no one may know your process better than you, leveraging independent perspective ensures your manufacturing process meets or surpasses the specified requirements to which they are being evaluated; in the instance it doesn’t meet specifications, you’ll know before someone from FDA does. These programs are also cost effective. For example, many firms may not be able to afford expertise on staff that has familiarity with GMP compliance. For small companies and those with limited financial and personnel resources, most of those resources will be dedicated to manufacturing and development, not necessarily quality assurance and quality systems. Often, when building an organization, the quality and regulatory departments are the last to be staffed. The limited resources, in combination with a perception of low risk for regulatory accountability, lead to a less than adequate level of conformance to any form of GMPs. Let’s face it: FDA is not going to help a manufacturer get into compliance. The agency will simply tell you what you did wrong, not how you can do it right, which means the money you thought you saved will most likely be diverted to legal fees. This is one area where third-party programs have always provided great value.

Most importantly is that products that are manufactured by third-party GMP certified firms are accepted immediately and sought after in the marketplace. This is because consumers, retailers and distributors recognize, and have confidence in, the third-party certification as an assurance of safety and performance. Consumers, retailers and distributors also know if there is a problem with the product, there is a complaint-handling system to ensure these products are identified and quickly removed from the marketplace.

A company must exercise due diligence, regardless of the low risk of regulatory agency involvement, to assure the quality and safety of the material being produced. While FDA will most likely not have more resources to enforce the final rule than at present, early adoption of GMPs by a company is vital and extremely helpful to future business success. With current estimates placing the number of U.S. dietary supplement manufacturers in the thousands, with approximately 100 companies currently GMP certified by a third-party program (combining the Natural Products Association’s, NSF’s and USP’s), it is probably accurate to say a significant number of firms would have to make substantial efforts, perhaps even disrupt their usual operations, to move toward compliance. And for a number of others, the final GMP ruling may represent a significant increase in the level of documentation and testing. In contrast, for a firm that has undergone certification, the transition to the federal GMP ruling will be relatively seamless.

Is not being prepared for FDA’s GMP regulation a business risk your firm can afford to take? Moreover, how do you continue to instill confidence in retailers and consumers that you’re adequately meeting GMP standards? Successful industry program inspections result in a report that can be used to demonstrate a specific level of excellence to customers, generate new business, and support product export efforts.

Some industry firms maintain FDA will eventually let manufacturers know they must apply GMPs, so why would they need a third-party to tell them this is something they should do and how to do it? Once it is (finally) established that GMPs must be applied, the next challenge for firms is to figure out how best to apply them—this is the key. Third-party certification programs have the experience and knowledge to help a company apply and integrate a GMP system flexible to the stage of the firm’s development. Will the flexibility of the stage of your development be very interesting to the FDA auditors when they knock on your door? FDA inspections are intended to find problems and evidence of non-compliance; self-regulatory programs serve to confirm compliance with a set of standards and generally encourage ongoing improvement.

For decades, the natural products industry has recognized the important role effective self-regulation can play, and has worked to develop sound self-regulatory initiatives. Well-constructed industry self-regulatory efforts offer several advantages over government regulation or legislation.

Self-regulation often can be more prompt, flexible and effective than government regulation. Self-regulatory programs are also generally more responsive to emerging technologies as well as dealing with potential problems that can permit application of the accumulated judgment and experience of an industry to issues that are sometimes difficult for the government to define with bright-line rules. Perhaps most importantly, participation in a third-party certification system is an unambiguous way to say to your customers—and the rest of the world—that you want and are willing to do what it takes to ensure your products meet the highest standards in the industry.

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines